Mozobil for Autologous Hematopoietic Stem Cell Transplantation
NCT07188090 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-11-28
Summary
This prospective trial investigates the approach of G-CSF with risk-adapted Plerixafor use for stem cell mobilization in patients undergoing autologous stem cell transplantation. Since FDA approval in 2008, Plerixafor has been combined with G-CSF to mobilize stem cells, though this regimen has been associated with a potentially higher incidence of engraftment syndrome.
The trial aims to evaluate whether using G-CSF alone, with selective use of Plerixafor, can achieve adequate stem cell collection while possibly reducing the incidence of engraftment syndrome.
Conditions
Interventions
- DRUG
-
Plerixafor
Plerixafor is an antagonist of chemokine receptor-4 (CXCR4) receptor that can release stem cells from the bone marrow niche into the peripheral blood circulation
- DRUG
-
Gcsf
All patients will receive G-CSF (peg-filgrastim or filgrastim) starting on day -4, prior to planned peripheral blood stem cell collection on day 0.
Sponsors & Collaborators
-
Thomas Jefferson University
lead OTHER
Principal Investigators
-
Xia Bi, MD, MS · [email protected]
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-16
- Primary Completion
- 2027-12-31
- Completion
- 2028-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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